We have discovered a surgical filament suitable for use as a suture or ligature that comprises a multifilament core having a plurality of filaments that are oriented having an external surface and internal interstices; and an outer coating that bonded to the external surface of the core but does not penetrate into the internal interstices of the core and a process for making these sutures.
|
1. A surgical filament suitable for use as a suture or ligature that comprises a multifilament core having a plurality of filaments that are oriented having an external surface and internal interstices; and an outer coating that bonded to the external surface of the core but does not penetrate into the internal interstices of the core.
17. A process for forming a surgical filament suitable for use as a suture or ligature comprising: meltcoating the external surface of an oriented biocompatible multifilament core with a melted biocompatible polymer wherein the melted biocompatible polymer is cooled to form an outer coating that bonds to the external surface of the multifilament core but does not penetrate into the internal interstices of the multifilament core.
3. The surgical filament of
5. The surgical filament of
6. The surgical filament of
8. The surgical filament of
9. The surgical filament of
10. The surgical filament of
12. The surgical filament of
14. The surgical filament of
15. The surgical filament of
16. The surgical filament of
|
|||||||||||||||||||||||||||||||||||||||||||||
This Appln claims benefit of provisional appln No. 60/099,857, filed Sep. 11, 1998.
The present invention relates to surgical filaments and more specifically to flexible multifilament sutures with a smooth surface.
Multifilament and monofilament sutures are commonly employed in surgical procedures. Multifilament sutures were the first sutures developed from natural fibers such as silk. Multifilament sutures generally have a braided or twisted construction. These constructions provide sutures with significant flexibility and strength. However, multifilament sutures tend to abrade tissue as the sutures are passed through the tissue thereby damaging the tissue. The tissue drag generated by the suture abrasion also requires the surgeon to use more force to overcome the tissue's resistance to the suture. To reduce tissue drag and make it easier for surgeons to tie knots in multifilament sutures, sutures are often solution coated with a lubricious coating. This allows a knot to be tied and slid down easily without the "chatter" normally associated with and uncoated braided suture. Sutures are typically coated by immersing the suture in a coating solution containing a solvent and a lubricious material. Lubricious materials are commonly low molecular weight waxy aliphatic polyesters. Unfortunately the coating polymers also penetrate into the internal interstice of the suture so it is often necessary to pliabilize the sutures after coating to restore their flexibility. Although these coatings significantly reduce tissue drag, and make it easier to tie knots in these sutures, they do not completely solve the tissue abrasion and tie down issues.
Monofilament sutures provide some advantages over multifilament sutures. Monofilament sutures have a smooth uniform surface and therefore have less tissue drag. However, monofilaments tend to be stiffer and more difficult to tie secure knots than in equivalent multifilament sutures. To overcome these deficiencies in suture design several approaches have been tried.
Hunter et al. in U.S. Pat. No. 3,791,388 developed a multifilament suture that was impregnated with a binder and covered with a helical ribbon winding. Although this suture certainly improved the smoothness of multifilament sutures, the process for making this suture was slow and the binder tended to make the suture stiffer than was desirable. Schmitt et al. and Landi et al. in U.S. Pat. No. 3,982,543 and 4,043,344, respectively, described extruding a lubricious sheath over a multifilament core. Schmitt's approach was to use a wire coating technique like those described in U.S. Pat. Nos. 2,735,258; 2,401,291; and 2,824,485. These earlier patents describe how to make tennis strings from nylon yarns by applying multiple coats of a nylon containing solution to the nylon yarn and drying between separate application of the coating. This process provides a tough and wiry fiber well suited for tennis rackets. This process also tends to fill the interstices of the nylon yarn (see column 2 lines 20-24 of U.S. Pat. No. 2,824,485). Landi describes coating a suture by placing the suture in a split die. The die is raised to a temperature about 20°C above the melting point of a lubricious bioabsorbable coating copolymer that has been melted and the suture is slowly passed through the molten material in the die and collecting after the coating has solidified. Unfortunately both of these process will result in the coating being distributed into the interstices of the multifilament suture which will significantly stiffen the suture.
Kurtz et al. in WO 86/00020 also describes coating multifilament sutures with film-forming materials commonly used in the construction of absorbable and non-absorbable sutures. Kurtz indicates that the coating material will penetrate and fill the interstices of the core to increase the lateral strength of the core fibers and avoid the tendencies of these core fibers to abrade, kink or fibrillate. The coating will be added in an amount sufficient to not only fill all the interstices of the multifilament core, but also to coat the surface of the yarn or thread component. In a preferred embodiment the composite so formed is further coated by melt extruding a coating material onto the composite.
Unfortunately, the helical windings and filled interstical spaces described by the prior art patent applications and patents provide a suture that is too stiff and rigid to be used in place of multifilament sutures in many surgical applications. It is an object of the present invention to provide a desirable surgical suture that combines the flexibility of multifilament sutures with the strength of monofilament sutures.
FIG. 1 is a schematic drawing of the inventive suture.
FIG. 2A is a scanning electron photomicrograph of an uncoated suture.
FIG. 2B is a scanning electron photomicrograph of the suture in FIG. 2A after coating which is one embodiment of the present invention.
FIG. 3 is a schematic drawing that illustrates one process for manufacturing the inventive sutures.
FIG. 4 is an enlarged schematic drawing of melt coating die assembly 2.
FIG. 5 is a graphical presentation of a comparison of the suture roughness of a polyester suture and two coated inventive sutures.
We have discovered a surgical filament suitable for use as a suture or ligature that comprises a multifilament core having a plurality of filaments that are oriented having an external surface and internal interstices; and an outer coating that is bonded to the external surface of the core but does not penetrate into the internal interstices of the core.
We have also discovered a solvent-free process for forming surgical filaments comprising extruding a biocompatible coating on the external surface of a multifilament core having a plurality of filaments that have been previously drawn at a temperature below the melting temperature of the multifilament core wherein the biocompatible coating adheres to the external surface of the multifilament core but does not penetrate the interstices of the core.
These and other embodiments of the present invention will become readily apparent to one skilled in the art from the following Detailed Description and Examples.
The core of the surgical ligature may be composed of any suitable biocompatible multifilament assembly that is oriented. The multifilament core can be a bundle of individual filaments, a yarn or tow (that may be entangled, twisted or plied) or filaments or yarns that have been braided, knitted or woven. Currently it is preferred to use a braided or knitted ligature made from a plurality of yarns. Suitable braided constructions for suture are described in U.S. Pat. Nos. 5,019,093; 5,059,213 and 4,959,069 (the disclosures of which are hereby incorporated by reference herein). At least one of the filaments in the multifilament core should be oriented so that a significant number of the molecules within the fiber are positioned substantially parallel to the length of the fiber to impart strength parallel to the fibers length. Preferably a significant number of the core filaments will be oriented to provide strength to the inventive suture and most preferably all of the core filaments will be oriented. Synthetic fibers the filaments are generally drawn at least 2 times their original length to orientation the molecules in the fibers and preferably in the range of about 2 to about 20 times their original length. Some processing techniques allow even higher draw ratios. Suitable methods for forming and orienting the biocompatible fibers are well known in the art. Suitable multifilament biocompatible ligature materials are also well known in the art. Examples of nonabsorbable ligature materials include, but are not limited to, silk, polyesters (such as polybutylene terephthalate, polyethylene terephthalate, polybutester (such as Hytrel™ polybutester manufactured by DuPont, DE, USA and blends thereof), polyvinylidene fluoride and copolymers thereof (as is described in U.S. Pat. Nos. 4,564,013 and 5,219,659 which are incorporated herein), polyolefins (such as polyethylene, polypropylene and copolymers thereof as described in U.S. Pat. Nos. 4,520,822 and 4,557,264 which are incorporated herein), polyamides (such as nylons e.g. nylon 6, nylon 66, nylon 610, nylon 12, etc. and aromatic polyamides as described in WO 86/00020 which is incorporated herein). Silk is generally described as a nonabsorbable suture material, however, current evidence indicates that it is degraded by the body. Examples of absorbable ligature materials include but are not limited to homopolymers, copolymers (including polymers containing two or more monomers having random and non-random structures) and blends of aliphatic polyesters, polyoxaesters, polyoxaamides, polyoxaesters containing amido groups, polyanhydrides, polyorthoesters, and combinations thereof. Suitable aliphatic polyesters may be make from monomers that generally have the formula: ##STR1##
These monomers (or equivalent acids if any) may be polymerized to provide polymers of the following general structures:
[--O--R5 --C(O)--]B IX
(H[--O--R9 --C(O)]p --O--)L G X
wherein R5 and R9 are independently selected from the group consisting of --CH2 --CH2 --O--CH2 --, --CR8 H--CH2 --, --(CH2)3 --O--, --C (R6) (R7)--, --C (R6) (R7)--C (O)--O--C (R6) (R7)--, --(CH2)K --C (O)--CH2 --, --(CH2)5 --, --(CH2)F --O--C(O)--; and R6 and R7 are independently selected from the group consisting of hydrogen and an alkyl containing from 1 to 8 carbon atoms; R8 is selected from the group consisting of hydrogen and methyl; F and K are integers in the range of from 2 to 6; B is an integer in the range of from 1 to n such that the number average molecular weight of formula IX is less than about 500,000, preferably less than about 80,000; P is an integer in the range of from 1 to m such that the number average molecular weight of formula X is less than about 1,000,000, preferably less than about 200,000, preferably less than about 40,000 and most preferably less than 20,000; G represents the residue minus from 1 to L hydrogen atoms from the hydroxyl groups of an alcohol previously containing from 1 to about 200 hydroxyl groups; and L is an integer from about 1 to about 2. Preferably G will be the residue of a dihydroxy alcohol minus both hydroxyl groups. Suitable monomers include lactic acid, lactide (d, l and meso lactide and blends thereof), glycolic acid, glycolide, ε-caprolactone, p-dioxanone, 6,6-dimethyl-1,4-dioxepan-2-one, trimethylene carbonate, 1,4-dioxepan-2-one, 1,5-dioxepan-2-one and combinations thereof.
The biocompatible coating may be utilize the same biocompatible synthetic polymers described above for use in making the core filaments provided that the temperature that the core filaments will be exposed to during coating does not melt the core filaments or substantially reduce the molecular orientation of the polymer chains of the core filaments. For the purpose of this invention the coating forms a surface that is independent of the underlying shape of the filament core but bonded to the external surface of the core. The coating layer is preferably melt coated onto the external surface of the core filaments to provide a cross section of the desired shape such as a circle, a triangle with rounded corners, polygonal or other desired shape. A smoother surface is provided thereby reducing the tissue drag associated with multifilament suture. Additionally, because only the external surface of the core is bonded to the coating layer the internal filaments in the core are free to move and provide flexibility to the ligature. The coating, however, should be bonded to the core's external surface so that it will not peel, strip or separate after tying at least 4 throws (two complete surgeon's square knots). Example 8 describes how these knots are tied.
The coating thickness should be sufficient to substantially reduce or eliminate the hills and valleys normally associated with the surfaces of multifilament constructions. To fill in the space between the filaments in the core and provide the desired smooth external surface, the coating layer thickness generally should average at least 1/4 of the diameter of the filaments used in the core and preferably will average at least 1/2 of the diameter of the filaments used in the core. The coating layer thickness for ligatures constructed from yarns (i.e. with a diameter of about 13 microns) will generally average from about 5 microns to about 125 microns and preferably will average in the range of from about 5 to about 25 microns.
The biocompatible synthetic polymers used in the coating layer may be homopolymers, copolymers or blends of the previously described biocompatible polymers used in making the core filaments. The coating layer must be formed from a non-friable biocompatible synthetic polymer. Generally, but in no way limiting the scope of this invention, we believe that polymers with a molecular weight of greater than 10,000 will be preferred for use as coating polymers.
If the coating layer is bioabsorbable it may also contain various medicaments (such as antimicrobial agents i.e. antibiotics or silver compounds) therapeutic (such as antiinflammatory agents) and other biologically active materials (such as growth factors). The outer surface of the coated ligature may also be coated with an additional lubricant to further enhance its knot slide.
In one embodiment of the present invention as illustrated in FIGS. 3 and 4. In FIG. 3 the uncoated filaments 9 are taken from a spool 1 and passed through a melt coating die assembly 2 to be coated with a coating material 11. The spool may have a frictional brake or other tensioning device to assure a uniform feed rate of the filaments into the melt coating die assembly 2. Suitable melt coating dies are commercially available from Canterberry Engineering, USA. The coating material 11 is feed into hopper 5. The coating material 11 will pass from hopper 5 into extruder barrel 4 and be melted. The melted coating material 11 will them be pumped at a constant pressure or rate through a melt metering device 3 to coating die assembly 2. As is illustrated in FIG. 4 the melted coating material 11 is pumped into inlet 215 of the coating die assembly body 225 and passes through passage way 207 to chamber 219 where the melted coating material 11 contact the uncoated filaments 9. The uncoated filaments enter the coating assembly 2 through passage 216 in the core tube 213. Attached to the end of the core tube is a tapered guider tip 212, which terminates in chamber 219. Chamber 219 is bounded by guider tip 212 and die 214 that are adjustably maintained in position by the coating die assembly 225. The uncoated filaments 9 contact the melted coating material in chamber 219, become coated with the melt coating material 11 and pass through the chamber to outlet 221. The coated ligature 10 is then cooled to solidify the melted coating material preferably in a liquid bath 6. Once the coating material has solidified on the coated filaments the coated filaments are collected preferably by passing the coated ligature over godets rolls 7 then on to a take-up stand 8.
In another embodiment of the present invention which is not specifically illustrated, the guider tip 212 could extend to outlet 221 where the uncoated core filaments would first contact the melted coating material 11.
Additionally, the surgical filament may be woven or knitted into various surgical textiles such as barriers, scaffolds, meshes, and the like, and having coating and film added thereto. The surgical textiles may thereafter be further processed. The following non-limiting examples are provided to further illustrate the practice of the present invention.
An absorbable melt coated ligature was made from a 75/25 poly(glycolide--co--caprolactone) segmented copolymer coated onto a 90/10 poly(glycolide-co-lactide) random copolymer braided multifilament substrate. The 75/25 poly(glycolide--co--caprolactone) segmented copolymer is used to make Monocryl™ Suture, sold by ETHICON, Inc. of Somerville, N.J., and described in U.S. Pat. No. 5,133,739, issued Jul. 28, 1992, Bezwada et al. assigned to Ethicon.
The 90/10 poly(glycolide--co--lactide) random copolymer braided multifilament substrate was that from which Vicryl™ Suture, sold by ETHICON, Inc. of Somerville, N.J., is made. This size 3/0 material would generally need to be solution coated with a lubricious coating, cut to length, needles attached, packaged, sterilized and sealed, to complete the existing manufacturing process.
In one embodiment of the present invention, the braided multifilament substrate was instead subjected to a melt coating process that bonded an outer coating to the external surface of the multifilament substrate (or core), but did not penetrate into the internal interstices of the core.
An extruder with a 1" diameter screw (Killion Extruder) was used with a pressure guider and die (Canterberry Engineering, P/N CEC 10177 and CEC 10124). The coating material (75/25 poly(glycolide--co--caprolactone) copolymer), in pellet form, was fed into the extruder hopper. The hopper was provided with a constant flow of nitrogen. The substrate was then fed through the pressure guider and die by attaching the substrate to a metallic guide wire and pushing the wire through the assembled guider. Another method used to feed the substrate through the guider and die involved feeding the substrate through the guider and die prior to assembly in the extruder. Once the substrate was fed, the guider and die were assembled into the extruder. The substrate was then fed through the rest of the coating line including the water bath, laser micrometer, godet rolls and take up unit. As is illustrated in FIG. 3. The coating material passed through the hopper into the extruder barrel and was melted. The melted material was then pumped at a constant rate through a melt-metering device. The melted coating material was then pumped around the guider tip and through the die where it encompassed the uncoated substrate and creates a coated structure. The take-up speeds and extrusion parameters were altered until a smooth and uniform coating was established. The conditions were monitored and documented in Table 1.
| TABLE 1 |
| Processing Conditions for a (75/25 PGA/PCL) polymer outer |
| coating over a braided, size 3/0, 90/10 poly (glycolide-co-lactide) |
| random copolymer multifilament core: |
| Process Conditions |
| Melt Temperature (° F.) 350 |
| Die Temperature (° F.) 340 |
| Pump Temperature (° F.) 360 |
| Block Temperature (° F.) 380 |
| Barrel Temperature - Zone 3 (° F.) 410 |
| Barrel Temperature - Zone 2 (° F.) 400 |
| Barrel Temperature - Zone 1 (° F.) 370 |
| Barrel Pressure (psi) 2500 |
| Pump Pressure (psi) 2500 |
| Die Pressure (psi) 850 |
| Take-up Speed (fpm) 23-39 |
| Die Orifice (mils) 14 |
A non-absorbable polyester ligature was made using a copolyester-ether elastomer coating material over a 20 polyethylene terephthalate braided substrate. The copolyester-ether elastomer is commercially available from Hoechst Celanese and was sold under the tradename Riteflex™ 655. The Riteflex™ 655 material is a copolyester thermoplastic elastomer with a hard and soft segment as shown below: ##STR2##
The polyethylene terephthalate braided structure is based on commercially available suture material from Ethicon Inc. (Somerville, N.J., USA), size 3/0 Mersilene™ Polyethylene Terephthalate Suture. The procedure followed is identical to that described in Example one with the exception of the processing conditions which are listed in Table 2. The processing conditions were altered, especially the extrusion temperatures and take up speed, to provide a smooth uniform outer surface.
| TABLE 2 |
| Processing conditions for a Riteflex ™ 655 (copolyester - |
| ether elastomer - Hoechst Celanese) polymer coating over |
| a 3/0 Mersilene ™ PET) Suture: |
| Process Conditions |
| Melt Temperature (° F.) 420 |
| Die Temperature (° F.) 410 |
| Pump Temperature (° F.) 440 |
| Block Temperature (° F.) 440 |
| Barrel Temperature - Zone 3 (° F.) 420 |
| Barrel Temperature - Zone 2 (° F.) 420 |
| Barrel Temperature - Zone 1 (° F.) 400 |
| Barrel Pressure (psi) 2500 |
| Pump Pressure (psi) 400 |
| Die Pressure (psi) 400 |
| Take-up Speed (fpm) 23 |
| Die Orifice (mils) 14 |
A non-absorbable ligature was made of an Ethylene-propylene copolymer coating material over a PET braided substrate. The Ethylene-propylene copolymer is commercially available from Exxon under the name Exact 3035 and can be represented as: ##STR3##
The procedure followed is identical to that described in Example one with the exception of the processing conditions which are listed in Table 3. The processing conditions were altered, especially the extrusion temperatures and take up speed, to provide a smooth uniform outer surface.
| TABLE 3 |
| Processing conditions for EXACT 3035 (Ethylene-propylene |
| copolymer - Exxon) coating over a 3/0 Mersilene ™ |
| (PET) Suture: |
| Process Conditions |
| Melt Temperature (° F.) 400 |
| Die Temperature (° F.) 400 |
| Pump Temperature (° F.) 400 |
| Block Temperature (° F.) 400 |
| Barrel Temperature - Zone 3 (° F.) 400 |
| Barrel Temperature - Zone 2 (° F.) 390 |
| Barrel Temperature - Zone 1 (° F.) 380 |
| Barrel Pressure (psi) 2500 |
| Pump Pressure (psi) 3000 |
| Die Pressure (psi) 3000 |
| Take-up Speed (fpm) 23-110 |
| Die Orifice (mils) 14 |
An absorbable ligature was made of a poly(p-dioxanone) coating material over a 90/10 PGA/PLA substrate. The poly(p-dioxanone) polymer can be represented as:
--[--CH2 CH2 --O--CH2 COO--]n --
The procedure followed is identical to that described in Example 1 with the exception of the processing conditions which are listed in Table 4. The processing conditions were altered, especially the extrusion temperatures and take up speed, to provide a smooth uniform outer surface.
| TABLE 4 |
| Processing Conditions for a Poly (p-dioxanone) polymer |
| coated over a Size 1 (90/10 PGA/PLA) Suture |
| Process Conditions |
| Melt Temperature (° F.) 260 |
| Die Temperature (° F.) 260 |
| Pump Temperature (° F.) 260 |
| Block Temperature (° F.) 260 |
| Barrel Temperature - Zone 3 (° F.) 260 |
| Barrel Temperature - Zone 2 (° F.) 255 |
| Barrel Temperature - Zone 1 (° F.) 250 |
| Barrel Pressure (psi) 1500 |
| Pump Pressure (psi) 3800 |
| Die Pressure (psi) 3200 |
| Take-up Speed (fpm) 40 |
| Die Orifice (mils) 26 |
A non-absorbable ligature was made by coating polypropylene polymer over a polyethylene terephthalate braided substrate. The polypropylene material can be represented as: ##STR4##
The polyethylene terephthalate braided structure is based on commercially available suture material from Ethicon Inc. (Somerville, N.J., USA), size 3/0 suture sold identified as Mersilene™ Polyethylene Terephthalate Suture. The procedure followed is identical to that described in Example one with the exception of the processing conditions which are listed in Table 5. The processing conditions were altered, especially the extrusion temperatures and take up speed, to provide a smooth uniform outer surface.
| TABLE 5 |
| Processing Conditions for a Polypropylene |
| (Homopolymer - Aristech) polymer coated over |
| Size 1 Mersilene ™ (PET) Suture: |
| Process Conditions |
| Melt Temperature (° F.) 380 |
| Die Temperature (° F.) 390 |
| Pump Temperature (° F.) 395 |
| Block Temperature (° F.) 390 |
| Barrel Temperature - Zone 3 (° F.) 395 |
| Barrel Temperature - Zone 2 (° F.) 390 |
| Barrel Temperature - Zone 1 (° F.) 360 |
| Barrel Pressure (psi) |
| Pump Pressure (psi) 500 |
| Die Pressure (psi) 250 |
| Take-up Speed (fpm) 100 |
| Die Orifice (mils) 26 |
A non-absorbable ligature was made of a high density polyethylene coating material over a braided PET substrate. The coating material was a High Density Polyethylene (HDPE) and can be represented as:
--[CH2 --CH2 ]n --
The polyethylene terephthalate braided structure is based on commercially available suture material from 20 Ethicon Inc. (Somerville, N.J., USA), size 2/0 Mersilene™ Polyethylene Terephthalate Suture. The procedure followed is identical to that described in
Example one with the exception of the processing conditions which are listed in Table 6. The processing conditions were altered, especially the extrusion temperatures and take up speed, to provide a smooth uniform outer surface.
| TABLE 6 |
| Processing Conditions for a High Density Polyethylene |
| (HDPE - Union Carbide) polymer coating over Size 2-0 |
| Mersilene ™ Polyethylene Terephthalate Suture: |
| Process Conditions |
| Melt Temperature (° F.) 510 |
| Die Temperature (° F.) 530 |
| Pump Temperature (° F.) 515 |
| Block Temperature (° F.) 515 |
| Barrel Temperature - Zone 3 (° F.) 500 |
| Barrel Temperature - Zone 2 (° F.) 475 |
| Barrel Temperature - Zone 1 (° F.) 330 |
| Barrel Pressure (psi) |
| Pump Pressure (psi) 1850 |
| Die Pressure (psi) 1500 |
| Take-up Speed (fpm) 800 |
| Die Orifice (mils) 26 |
A absorbable ligature was made of 85/15 poly(paradioxanone--co--lactide) copolymer coating material over a braided 90/10 poly(glycolide--co--lactide) random copolymer substrate. An extruder with a 5/8" diameter screw (Randcastle Extruder) with a sleeving die (Canterbury Engineering, CEC sleeving guider--0.014×0.054 and sleeving die 0.059) was used. The coating material was fed into the hopper. The coating material passed from the hopper into the extruder barrel and was melted. The substrate was then fed through the pressure guider and die by attaching the suture to a metallic guide wire and pushing the wire through the assembled guider. Another method used to feed the substrate through the guider and die involved feeding the substrate through the guider and die prior to assembly in the extruder. Once the substrate was fed, the guider and die were assembled into the extruder. The substrate was then fed through the rest of the coating line including the water bath, laser micrometer, godet rolls and take up unit. The melted coating material was then pumped at a constant pressure through a melt metering device to the coating die assembly. The melted coating was then pumped around the guider tip and through the die where it then encompassed the uncoated substrate and created a coated structure. The coated structure was then cooled to solidify the melted coating material in a water bath. The take-up speed and extrusion parameters were altered until a smooth and uniform coating was established. The conditions were monitored and documented in Table 7.
| TABLE 7 |
| Processing Conditions for a Absorbable coating 85%/15% |
| para-dioxanone-co-lactide copolymer over Size 2-0 |
| suture made from a 90/10 glycolide-co-lactide copolymer: |
| Process Conditions |
| Melt Temperature (° F.) 290 |
| Die Temperature (° F.) 280 |
| Barrel Temperature (° F.) Zone 3 280 |
| Barrel Temperature (° F.) Zone 2 270 |
| Barrel Temperature (° F.) Zone 1 220 |
| Melt Pressure (psi) 1000 |
| Screw Speed (rpm) 0.3 |
| Screw draw (amps) 0.5 |
| Take-up Speed (fpm) 9.5 |
| Die Diameter (in) 0.070 |
| Guider dimensions (in.) 0.040 × 0.060 |
The suture knot strength was determined by the following procedures:
A single suture is tied in a surgeon's square knot around an 8 mm in diameter mandrel. The square knot is tied in a consistent manner (left over right, right over left) and pulled taut after each throw.
Suture roughness tests, as reported in FIG. 5, were determined using the testing procedures described in U.S. Pat. No. 4,027,676, except that the roughness number presented in the FIG. was the average of the roughness (see FIG. 3 of U.S. Pat. No. 4,027,676) from the zero point.
Scalzo, Howard, Fischer, Jerome A., Zhou, Jianguo J.
| Patent | Priority | Assignee | Title |
| 10188384, | Jun 06 2011 | Ethicon, Inc | Methods and devices for soft palate tissue elevation procedures |
| 10420546, | May 04 2010 | Cilag GmbH International | Self-retaining systems having laser-cut retainers |
| 10441270, | Nov 03 2008 | Ethicon, Inc | Length of self-retaining suture and method and device for using the same |
| 10492780, | Mar 23 2011 | Cilag GmbH International | Self-retaining variable loop sutures |
| 10548592, | May 14 2004 | Cilag GmbH International | Suture methods and devices |
| 10779815, | May 14 2004 | Cilag GmbH International | Suture methods and devices |
| 10952721, | May 04 2010 | Cilag GmbH International | Laser cutting system and methods for creating self-retaining sutures |
| 11007296, | Nov 03 2010 | Cilag GmbH International | Drug-eluting self-retaining sutures and methods relating thereto |
| 11058792, | Jun 28 2018 | Ethicon, Inc | Readily absorbable copolymer compositions for high strength sutures having enhanced strength retention post-implantation |
| 11234689, | Nov 03 2008 | Ethicon, Inc | Length of self-retaining suture and method and device for using the same |
| 11234692, | May 04 2010 | Cilag GmbH International | Self-retaining system having laser-cut retainers |
| 11596709, | Jun 28 2018 | Ethicon, Inc. | Readily absorbable copolymer compositions for high strength sutures having enhanced strength retention post-implantation |
| 11690614, | Mar 23 2011 | Cilag GmbH International | Self-retaining variable loop sutures |
| 11723654, | May 14 2004 | Cilag GmbH International | Suture methods and devices |
| 6458148, | Mar 19 1999 | Aesculap AG | Strand-like implant of resorbable polymer material, process for its production and use in surgery |
| 6592515, | Sep 07 2000 | ASTORA WOMEN S HEALTH, LLC | Implantable article and method |
| 6703122, | Jul 03 2001 | PERFORMANCE FIBERS, INC | High-strength chemically resistant thin sheath fibers and methods of manufacture |
| 6878757, | Dec 11 2002 | Covidien LP | Antimicrobial suture coating |
| 6884212, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 7025063, | Sep 07 2000 | Boston Scientific Scimed, Inc | Coated sling material |
| 7070610, | Mar 30 2002 | SAMYANG HOLDINGS CORPORATION | Monofilament suture and manufacturing method thereof |
| 7141302, | Dec 14 2001 | Deutsche Institute fur Textil-und Faserforschung Stuttgart Stiftung des offentlichen Rechts | Suture material for surgery, processes for its production and the use thereof |
| 7517313, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 7996967, | Aug 31 2001 | Cilag GmbH International | System for variable-angle cutting of a suture to create tissue retainers of a desired shape and size |
| 7996968, | Aug 31 2001 | Cilag GmbH International | Automated method for cutting tissue retainers on a suture |
| 8007822, | Jan 24 2003 | Covidien LP | Bioabsorbable composition and coatings including same |
| 8011072, | Aug 31 2001 | Cilag GmbH International | Method for variable-angle cutting of a suture to create tissue retainers of a desired shape and size |
| 8015678, | Aug 31 2001 | Cilag GmbH International | Method for cutting a suture to create tissue retainers of a desired shape and size |
| 8020263, | Aug 31 2001 | Cilag GmbH International | Automated system for cutting tissue retainers on a suture |
| 8028387, | Aug 31 2001 | Cilag GmbH International | System for supporting and cutting suture thread to create tissue retainers thereon |
| 8028388, | Aug 31 2001 | Cilag GmbH International | System for cutting a suture to create tissue retainers of a desired shape and size |
| 8032996, | May 13 2004 | Cilag GmbH International | Apparatus for forming barbs on a suture |
| 8083770, | Aug 09 2002 | Ethicon, Inc | Suture anchor and method |
| 8118834, | Dec 20 2007 | Ethicon, Inc | Composite self-retaining sutures and method |
| 8147478, | Sep 07 2000 | Boston Scientific Scimed, Inc | Coated sling material |
| 8216273, | Feb 25 2008 | Cilag GmbH International | Self-retainers with supporting structures on a suture |
| 8246652, | May 03 1993 | Ethicon, Inc | Suture with a pointed end and an anchor end and with equally spaced yieldable tissue grasping barbs located at successive axial locations |
| 8303625, | Apr 18 2002 | HELMHOLTZ-ZENTRUM GEESTHACHT ZENTRUM FUR MATERIAL UND KUSTENFORSCHUNG; Helmholtz-Zentrum Geesthacht Zentrum Fuer Material- und Kuestenforschung GmbH | Biodegradable shape memory polymeric sutures |
| 8329205, | Jan 24 2003 | Covidien LP | Bioabsorbable composition and coatings of a fatty acid salt, epsilon-caprolactone, a monomer, and homopolymers or copolymers |
| 8460338, | Feb 25 2008 | Cilag GmbH International | Self-retainers with supporting structures on a suture |
| 8613184, | Oct 01 2009 | Babolat VS | Core for racket string, racket string comprising such a core and corresponding manufacturing method |
| 8615856, | Jan 30 2008 | Ethicon, Inc | Apparatus and method for forming self-retaining sutures |
| 8641732, | Feb 26 2008 | Ethicon, Inc | Self-retaining suture with variable dimension filament and method |
| 8652170, | Aug 09 2002 | Ethicon, Inc | Double ended barbed suture with an intermediate body |
| 8679158, | Aug 09 2002 | Ethicon, Inc | Multiple suture thread configuration with an intermediate connector |
| 8690914, | Aug 09 2002 | Ethicon, Inc | Suture with an intermediate barbed body |
| 8702586, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 8721664, | May 14 2004 | Cilag GmbH International | Suture methods and devices |
| 8721681, | Sep 30 2002 | Ethicon, Inc | Barbed suture in combination with surgical needle |
| 8734485, | Sep 30 2002 | Ethicon, Inc | Sutures with barbs that overlap and cover projections |
| 8734486, | Aug 09 2002 | Ethicon, Inc | Multiple suture thread configuration with an intermediate connector |
| 8747437, | Jun 29 2001 | Ethicon, Inc | Continuous stitch wound closure utilizing one-way suture |
| 8764776, | Jun 29 2001 | Ethicon, Inc | Anastomosis method using self-retaining sutures |
| 8764796, | Jun 29 2001 | Ethicon, Inc | Suture method |
| 8771313, | Dec 19 2007 | Cilag GmbH International | Self-retaining sutures with heat-contact mediated retainers |
| 8777987, | Sep 27 2007 | Ethicon, Inc | Self-retaining sutures including tissue retainers having improved strength |
| 8777988, | Jun 29 2001 | Ethicon, Inc | Methods for using self-retaining sutures in endoscopic procedures |
| 8777989, | Jun 29 2001 | Ethicon, Inc | Subcutaneous sinusoidal wound closure utilizing one-way suture |
| 8793863, | Apr 13 2007 | Cilag GmbH International | Method and apparatus for forming retainers on a suture |
| 8795332, | Sep 30 2002 | Ethicon, Inc | Barbed sutures |
| 8821540, | Sep 30 2002 | Ethicon, Inc | Self-retaining sutures having effective holding strength and tensile strength |
| 8834522, | Apr 18 2002 | Helmholtz-Zentrum Geestahacht Zentrum fur Material und Kustenforschung | Biodegradable shape memory polymeric sutures |
| 8852232, | Sep 30 2002 | Ethicon, Inc | Self-retaining sutures having effective holding strength and tensile strength |
| 8875607, | Jan 30 2008 | Cilag GmbH International | Apparatus and method for forming self-retaining sutures |
| 8876865, | Apr 15 2008 | Cilag GmbH International | Self-retaining sutures with bi-directional retainers or uni-directional retainers |
| 8905912, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 8915943, | Apr 13 2007 | Cilag GmbH International | Self-retaining systems for surgical procedures |
| 8916077, | Dec 19 2007 | Ethicon, Inc | Self-retaining sutures with retainers formed from molten material |
| 8926659, | Aug 31 2001 | Cilag GmbH International | Barbed suture created having barbs defined by variable-angle cut |
| 8932328, | Nov 03 2008 | Cilag GmbH International | Length of self-retaining suture and method and device for using the same |
| 8961560, | May 16 2008 | Ethicon, Inc | Bidirectional self-retaining sutures with laser-marked and/or non-laser marked indicia and methods |
| 8968362, | Apr 08 2010 | Covidien LP | Coated looped suture |
| 8979894, | Apr 08 2010 | Covidien LP | Coated looped suture |
| 9022921, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 9044225, | Dec 20 2007 | Ethicon, Inc | Composite self-retaining sutures and method |
| 9125647, | Feb 21 2008 | Ethicon, Inc | Method and apparatus for elevating retainers on self-retaining sutures |
| 9211177, | Sep 07 2000 | STASKIN, DAVID, MD, DR | Implantable article and method |
| 9248580, | Sep 30 2002 | Cilag GmbH International | Barb configurations for barbed sutures |
| 9498893, | Sep 27 2007 | Ethicon, Inc | Self-retaining sutures including tissue retainers having improved strength |
| 9675341, | Nov 09 2010 | ANGIOTECH PHARMACEUTICALS, INC | Emergency self-retaining sutures and packaging |
| 9687228, | Apr 08 2010 | Covidien LP | Coated looped suture |
| 9955962, | Jun 11 2010 | Cilag GmbH International | Suture delivery tools for endoscopic and robot-assisted surgery and methods |
| 9987113, | Sep 07 2000 | Astora Women's Health, LLC | Implantable article and method |
| Patent | Priority | Assignee | Title |
| 2401291, | |||
| 2735258, | |||
| 2824485, | |||
| 3791388, | |||
| 3982543, | Oct 18 1971 | American Cyanamid Company | Reducing capillarity of polyglycolic acid sutures |
| 4027676, | Jan 07 1975 | Ethicon, Inc. | Coated sutures |
| 4043344, | Sep 20 1976 | American Cyanamid Company | Non-absorbable surgical sutures coated with polyoxyethylene-polyoxypropylene copolymer lubricant |
| 4520822, | Sep 13 1983 | Ethicon, Inc. | Ethylene-propylene copolymer sutures |
| 4557264, | Apr 09 1984 | Ethicon Inc. | Surgical filament from polypropylene blended with polyethylene |
| 4564013, | May 24 1984 | Ethicon, Inc. | Surgical filaments from vinylidene fluoride copolymers |
| 4959069, | Oct 20 1989 | Ethicon, Inc. | Braided surgical sutures |
| 5019093, | Aug 26 1987 | United States Surgical Corporation | Braided suture |
| 5059213, | Mar 26 1990 | UNITED STATES SURGICAL CORPORATION, 150 GLOVER AVE , NORWALK, CT 06856 USA | Spiroid braided suture |
| 5133739, | Feb 16 1990 | Ethicon, Inc. | Segmented copolymers of ε-caprolactone and glycolide |
| 5219659, | Jul 30 1982 | Gerhard M., Krahmer | Suture material made of synthetic resin monofil |
| WO8600020, |
| Executed on | Assignor | Assignee | Conveyance | Frame | Reel | Doc |
| Aug 04 1999 | Ethicon, Inc. | (assignment on the face of the patent) | / | |||
| Sep 01 1999 | FISCHER, JEROME A | Ethicon, Inc | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 010228 | /0935 | |
| Sep 01 1999 | SCALZO, HOWARD | Ethicon, Inc | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 010228 | /0935 | |
| Sep 01 1999 | ZHOU, JIANGUO J | Ethicon, Inc | ASSIGNMENT OF ASSIGNORS INTEREST SEE DOCUMENT FOR DETAILS | 010228 | /0935 |
| Date | Maintenance Fee Events |
| Jul 28 2004 | M1551: Payment of Maintenance Fee, 4th Year, Large Entity. |
| Jul 22 2008 | M1552: Payment of Maintenance Fee, 8th Year, Large Entity. |
| Jul 11 2012 | M1553: Payment of Maintenance Fee, 12th Year, Large Entity. |
| Date | Maintenance Schedule |
| Feb 06 2004 | 4 years fee payment window open |
| Aug 06 2004 | 6 months grace period start (w surcharge) |
| Feb 06 2005 | patent expiry (for year 4) |
| Feb 06 2007 | 2 years to revive unintentionally abandoned end. (for year 4) |
| Feb 06 2008 | 8 years fee payment window open |
| Aug 06 2008 | 6 months grace period start (w surcharge) |
| Feb 06 2009 | patent expiry (for year 8) |
| Feb 06 2011 | 2 years to revive unintentionally abandoned end. (for year 8) |
| Feb 06 2012 | 12 years fee payment window open |
| Aug 06 2012 | 6 months grace period start (w surcharge) |
| Feb 06 2013 | patent expiry (for year 12) |
| Feb 06 2015 | 2 years to revive unintentionally abandoned end. (for year 12) |